510(k) · Cleared
ClearedHerniamesh T-Sling
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Herniamesh · PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
Cleared on May 15, 2002 as substantially equivalent to K974098 (ETHICON, Inc., 1998) and 1 other predicate after a 76-day review. Its family tree reaches back 1 generation to 1998. 19 later devices descend from it.
- Decided
- May 15, 2002
- Review
- 76 days
- Class
- Class II
- Product code
- PAH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K974098 (1998). 2 ancestors in all. 19 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK974098 Pubouurethral SlingETHICON, Inc. · 1998
- This deviceK020652 Herniamesh T-SlingHerniamesh · 2002
- Descendant · cites it directly · 13 of its ownK050516 T-SlingHerniamesh S.R.L. · 2006
- Descendant · 2 generations on · 10 of its ownK072456 Desara Mesh Sling, Model Cal-DS01Caldera Medical, Inc. · 2008
- Descendant · 3 generations on · 5 of its ownK101169 Desara Mesh Model: Cal-DS01Caldera Medical, Inc. · 2010
- Descendant · cites it directly · 4 of its ownK023898 Gyne Ideas Minitape RP DeviceGyne Ideas, Ltd. · 2003
- Descendant · 4 generations on · 3 of its ownK112609 Desara MeshCaldera Medical, Inc. · 2011
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K050516T-SlingHerniamesh S.R.L. · 2006 · cites it directly13descendants
- K072456Desara Mesh Sling, Model Cal-DS01Caldera Medical, Inc. · 2008 · 2 generations on10descendants
- K101169Desara Mesh Model: Cal-DS01Caldera Medical, Inc. · 2010 · 3 generations on5descendants
- K023898Gyne Ideas Minitape RP DeviceGyne Ideas, Ltd. · 2003 · cites it directly4descendants
- K112609Desara MeshCaldera Medical, Inc. · 2011 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974098 | Pubouurethral Sling | ETHICON, Inc. | 1998 | — |
| 0 (this device) | K020652 | Herniamesh T-Sling | Herniamesh | 2002 | — |
| +1 | K050516 | T-Sling | Herniamesh S.R.L. | 2006 | — |
| +2 | K072456 | Desara Mesh Sling, Model Cal-DS01 | Caldera Medical, Inc. | 2008 | — |
| +3 | K101169 | Desara Mesh Model: Cal-DS01 | Caldera Medical, Inc. | 2010 | — |
| +1 | K023898 | Gyne Ideas Minitape RP Device | Gyne Ideas, Ltd. | 2003 | — |
| +4 | K112609 | Desara Mesh | Caldera Medical, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PAH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PAH device
- #1 K242473 Altis Single Incision Sling System (519650)…score 10.9 · 10 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K974098 | Pubouurethral SlingSummary page 4…of Similarities and Differences / Substantial Equivalence to Predicate Devices Feature Herniamesh T-Sling Ethicon TVT Injectx Inc BioSlingTM 510(k) No. To be determined K974098 K010533 Classification Class II: Polymeric Surgical Class IL: Polymeric Class II: Polymeric Mesh Surgical Mesh Surgical Mesh Ind… | 1998 |
| * | K010533 | Biosling - Bioabsorbable Polymer Sling & Surgical MeshSummary page 4…arities and Differences / Substantial Equivalence to Predicate Devices Feature Herniamesh T-Sling Ethicon TVT Injectx Inc BioSlingTM 510(k) No. To be determined K974098 K010533 Classification Class II: Polymeric Surgical Class IL: Polymeric Class II: Polymeric Mesh Surgical Mesh Surgical Mesh Indication… | 2001 |
What descends from it? (19)
See all 192 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All PAH devicesPAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · PAH
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PAH
128in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PAH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PAH
242in 2025
MAUDE reports naming product code PAH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 3 | 61 | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 7 |
| 2012 | 4 | 128 | 0 | 129 |
| 2013 | 0 | — | 0 | 2,386 |
| 2014 | 0 | — | 0 | 338 |
| 2015 | 0 | — | 1 | 275 |
| 2016 | 0 | — | 0 | 697 |
| 2017 | 0 | — | 0 | 127 |
| 2018 | 0 | — | 0 | 174 |
| 2019 | 0 | — | 0 | 298 |
| 2020 | 1 | — | 0 | 171 |
| 2021 | 0 | — | 0 | 318 |
| 2022 | 0 | — | 0 | 159 |
| 2023 | 1 | — | 0 | 154 |
| 2024 | 1 | — | 0 | 287 |
| 2025 | 0 | — | 0 | 242 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Herniamesh T-sling is a dual-component pubourethral sling for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020652 · printed Nov 3, 2026
Cite this page
510(k) Report. “K020652: Herniamesh T-Sling.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K020652
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026